Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

• Status: Terminated
• Trial end date: 2020-09-23
• Target enrollment: 0
• Participant gender: All

Summary

A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Talazoparib

Criteria

Inclusion Criteria:

• Germline BRCA 1/2 Mutation Positive

• Women and men at least 18 years of age or older.

• Histologically confirmed invasive adenocarcinoma of the breast

• HER2 negative breast cancer as defined by ASCO-CAP criteria

• Tumor greater than or equal toT1, N0-3

• No evidence of distant metastasis

• Adequate bone marrow, hepatic, and renal function

• ECOG performance status 0 or 1

Exclusion Criteria:

• Any other previous antitumor therapies for the current cancer event. Treatment for ductal carcinoma in situ (DCIS) is allowed; ie, surgery, hormonal therapy and radiation.

• Evidence of distant metastasis apparent prior to randomization

• Patients with inflammatory breast carcinoma

• Malignancy within the last 3 years, except: Stage 1 melanoma which does not require any further treatment after adequate surgical excision; adequately treated non melanoma skin cancer; Curatively treated in situ cancer of the cervix; Stage 1, Grade 1 endometrial carcinoma; or Adequately treated contralateral breast carcinoma which has been disease free for a year; Other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for 5 years.

• Previous or concomitant systemic anti cancer therapies used for the treatment of cancer in the last 3 years.

• Prior treatment with a PARP inhibitor in any disease setting

• Concomitant use of Strong P gp inhibitors or inducers or BCRP inhibitors

• Patients who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol

• Major surgery within 14 days prior to study entry

• Known history of cardiac disease, for example : Myocardial infarction or symptomatic cardiac ischemia within 24 weeks before screening; Congestive heart failure New York Heart Association Class III or IV; History of clinically significant ventricular arrhythmias within one year prior to randomization; History of Mobitz II second degree or third degree heart block, uncontrolled hypertension.

• Active clinically significant infection

• Clinically significant bleeding diathesis or coagulopathy

• Non healing wound, ulcer or bone fracture

• Known hypersensitivity to any of the components of talazoparib

• Patients with myelodysplastic syndrome/acute myeloid leukemia

• Patients with uncontrolled seizures.

• Any evidence of other disease or any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatment